What you should know before getting started with SEROQUEL XR

What does the XR in SEROQUEL XR mean?

The XR in SEROQUEL XR stands for extended release. This means that medication is released around the clock. SEROQUEL XR is taken once daily as prescribed by your health care professional.

How should I be taking SEROQUEL XR?

SEROQUEL XR is an extended-release tablet you take by mouth. SEROQUEL XR tablets should be swallowed whole. The tablets should not be crushed, chewed, or split. Extended-release SEROQUEL XR should be taken as prescribed by your health care professional.

What should I do if I miss a dose?

If you miss a dose, take it as soon as you remember. If it is close to the next dose, skip the missed dose. Just take the next dose at your regular time. Do not take 2 doses at the same time unless your health care provider tells you to. If you are not sure about your dosing, call your health care provider.

When should I take SEROQUEL XR?

Take SEROQUEL XR only the way your health care professional tells you to. Your health care professional may recommend that you take SEROQUEL XR once daily in the evening (for example, 3-4 hours before bedtime).

Do I have to take SEROQUEL XR with food?

SEROQUEL XR should be taken without food or with a light meal (approximately 300 calories).

How soon can I expect results from SEROQUEL XR?

Everyone responds differently to therapy, so try to be patient and follow the directions of your health care professional. It is important to take SEROQUEL XR exactly as your health care professional has prescribed.

What are the most common side effects of SEROQUEL XR?

The most common side effects of SEROQUEL XR in adults across all indications are drowsiness, dry mouth, constipation, dizziness, increased appetite, upset stomach, weight gain, fatigue, disturbance in speech and language, and stuffy nose. This is not a complete list of the side effects of SEROQUEL XR. Learn more about common SEROQUEL XR side effects.

What are the possible side effects of SEROQUEL XR?

SEROQUEL XR can cause serious side effects, including:

Stroke that can lead to death can happen in elderly people with dementia who take medicines like SEROQUEL XR

Neuroleptic malignant syndrome (NMS)

High blood sugar (hyperglycemia)

High fat levels in your blood (increased cholesterol and triglycerides)

Increase in weight (weight gain)

Movements you cannot control in your face, tongue, or other body parts (tardive dyskinesia)

What should I tell my health care provider before taking SEROQUEL XR?

Before taking SEROQUEL XR, tell your health care provider if you have or have had

Diabetes or high blood sugar in you or your family: your health care provider should check your blood sugar before you start SEROQUEL XR and also during therapy

High levels of total cholesterol, triglycerides or LDL-cholesterol or low levels of HDL-cholesterol

Low or high blood pressure

Low white blood cell count

Cataracts

Seizures

Abnormal thyroid tests

High prolactin levels

Heart problems

Liver problems

Any other medical condition

Pregnancy or plans to become pregnant. It is not known if SEROQUEL XR will harm your unborn baby

Breast-feeding or plans to breast-feed. It is not known if SEROQUEL XR will pass into your breast milk. You and your health care provider should decide if you will take SEROQUEL XR or breast-feed. You should not do both

Tell the health care provider about all the medicines that you take or recently have taken including prescription medicines, nonprescription medicines, herbal supplements and vitamins. SEROQUEL XR and other medicines may affect each other causing serious side effects. SEROQUEL XR may affect the way other medicines work, and other medicines may affect how SEROQUEL XR works. Especially tell your health care provider if you take or plan to take medicines for:

Depression

High blood pressure

Parkinson's disease

Trouble sleeping

Also tell your health care provider if you take or plan to take any of these medicines:

Phenytoin, divalproex or carbamazepine (for epilepsy)

Barbiturates (to help you sleep)

Rifampin (for tuberculosis)

Glucocorticoids (steroids for inflammation)

Thioridazine (an antipsychotic)

Ketoconazole, fluconazole or itraconazole (for fungal infections)

Erythromycin (an antibiotic)

Protease inhibitors (for HIV)

This is not a complete list of medicines that can affect or be affected by SEROQUEL XR. Your doctor can tell you if it is safe to take SEROQUEL XR with your other medicines. Do not start or stop any medicines while taking SEROQUEL XR without talking to your health care provider first. Know the medicines you take. Keep a list of your medicines to show your health care provider and pharmacist when you get a new medicine.

Tell your health care provider if you are having a urine drug screen because SEROQUEL XR may affect your test results. Tell those giving the test that you are taking SEROQUEL XR.

What should I avoid while taking SEROQUEL XR?

Do not drive, operate machinery, or do other dangerous activities until you know how SEROQUEL XR affects you. SEROQUEL XR may make you drowsy

Avoid getting overheated or dehydrated

Do not over-exercise

In hot weather, stay inside in a cool place if possible

Stay out of the sun. Do not wear too much or heavy clothing

Drink plenty of water

Do not drink alcohol while taking SEROQUEL XR. It may make some side effects of SEROQUEL XR worse

Is there any help available with the cost of my SEROQUEL XR prescription?

Talk to your health care professional to find out whether SEROQUEL XR is right for you. SEROQUEL XR is covered on most commercial insurance plans. In addition, you could be eligible for monthly savings on out-of-pocket costs over $15.* Be sure to read the eligibility requirements.

Important Safety Information About SEROQUEL XR

Elderly patients with dementia-related psychosis (having lost touch with reality due to confusion and memory loss) treated with this type of medicine are at an increased risk of death, compared to placebo (sugar pill). SEROQUEL XR is not approved for treating these patients.

Antidepressants have increased the risk of suicidal thoughts and actions in some children, teenagers, and young adults. Patients of all ages starting treatment should be watched closely for worsening of depression, suicidal thoughts or actions, unusual changes in behavior, agitation, and irritability. Patients, families, and caregivers should pay close attention to any changes, especially sudden changes in mood, behaviors, thoughts, or feelings. This is very important when an antidepressant medicine is started or when the dose is changed. These symptoms should be reported immediately to the doctor. SEROQUEL XR is not approved for children under the age of 10 years.

Do not take SEROQUEL XR if you are allergic to quetiapine fumarate or any of the ingredients in SEROQUEL XR.

Stroke that can lead to death can happen in elderly people with dementia who take medicines like SEROQUEL XR.

Stop SEROQUEL XR and call your doctor right away if you have some or all of the following symptoms: high fever; excessive sweating; stiff muscles; confusion; changes in pulse, heart rate, and blood pressure. These may be symptoms of a rare, but very serious and potentially fatal, side effect called neuroleptic malignant syndrome (NMS).

High blood sugar and diabetes have been reported with SEROQUEL XR and medicines like it. If you have diabetes or risk factors such as obesity or a family history of diabetes, your doctor should check your blood sugar before you start taking SEROQUEL XR and also during therapy. If you develop symptoms of high blood sugar or diabetes, such as excessive thirst or hunger, increased urination, or weakness, contact your doctor. Complications from diabetes can be serious and even life threatening.

Increases in triglycerides and in LDL (bad) cholesterol and decreases in HDL (good) cholesterol have been reported with SEROQUEL XR. Your doctor should check your cholesterol levels before you start SEROQUEL XR and during therapy.

Tell your doctor about any movements you cannot control in your face, tongue, or other body parts, as they may be signs of a serious condition called tardive dyskinesia (TD). TD may not go away, even if you stop taking SEROQUEL XR. TD may also start after you stop taking SEROQUEL XR.

Other risks include feeling dizzy or lightheaded upon standing, decreases in white blood cells (which can be fatal), or trouble swallowing. Tell your doctor if you experience any of these.

Before starting treatment, tell your doctor about all prescription and nonprescription medicines you are taking. Also tell your doctor if you have or have had low white blood cell count, seizures, abnormal thyroid tests, high prolactin levels, heart or liver problems, or cataracts. An eye exam for cataracts is recommended at the beginning of treatment and every 6 months thereafter.

Since drowsiness has been reported with SEROQUEL XR, you should not participate in activities such as driving or operating machinery until you know that you can do so safely. Avoid becoming overheated or dehydrated while taking SEROQUEL XR. Do not drink alcohol while taking SEROQUEL XR.

Tell your doctor if you are pregnant or intend to become pregnant. Avoid breast-feeding while taking SEROQUEL XR.

The most common side effects are drowsiness, dry mouth, constipation, dizziness, increased appetite, upset stomach, weight gain, fatigue, disturbance in speech and language, and stuffy nose.

Do not stop taking SEROQUEL XR without talking to your doctor. Stopping SEROQUEL XR suddenly may cause side effects.

This is not a complete summary of safety information. Please discuss the full Prescribing Information with your health care provider.

Approved Uses

SEROQUEL XR is a once-daily tablet approved in adults for (1) add-on treatment to an antidepressant for patients with major depressive disorder (MDD) who did not have an adequate response to antidepressant therapy; (2) acute depressive episodes in bipolar disorder; (3) acute manic or mixed episodes in bipolar disorder alone or with lithium or divalproex; (4) long-term treatment of bipolar disorder with lithium or divalproex; and (5) schizophrenia.

Please read the accompanying Medication Guide and full Prescribing Information, including Boxed WARNINGS.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.FDA.gov/medwatch or call 1-800-FDA-1088. This site is intended for US consumers only.

The information on this Web site should not take the place of talking with your doctor or health care professional. If you have any questions about your condition, or if you would like more information about SEROQUEL XR, talk to your doctor or pharmacist. Only you and your health care professional can decide if SEROQUEL XR is right for you.

Patient photos are intended to be representative of typical patients with bipolar disorder and/or major depressive disorder and are not of actual patients.